Evaluation of weight reduction programmes in the "Lighten Up" service in South Birmingham primary care trust (PCT)

ISRCTN	ISRCTN25072883
DOI	https://doi.org/10.1186/ISRCTN25072883
Secondary identifying numbers	Version 4

Submission date: 19/01/2009
Registration date: 06/03/2009
Last edited: 20/12/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kate Jolly
Scientific

Unit of Public Health, Epidemiology and Biostatistics
Public Health Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 414 7552
Email	c.b.jolly@bham.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Evaluation of weight reduction programmes in the "Lighten Up" service in South Birmingham primary care trust (PCT): a randomised controlled trial
Study acronym	Lighten Up
Study objectives	The weight loss programmes (Weight Watchers®, Slimming World, Rosemary Conley, NHS Size Down, pharmacy and general practice provision) will each achieve significantly greater weight loss at 3 months follow-up than the comparison group of exercise at a leisure centre. There will be no differences between the weight loss services in weight loss at 3 months.
Ethics approval(s)	South Birmingham Research Ethics Committee, approved on 19/12/2008 (ref: 08/H1207/331)
Health condition(s) or problem(s) studied	Obesity
Intervention	Participants will be allocated to one of the following eight arms: 1. Commercial weight loss programme: Weight Watchers 2. Commercial weight loss programme: Slimming World 3. Commercial weight loss programme: Rosemary Conley 4. Size Down (NHS community-based group programme) 5. Pharmacy-led obesity services 6. General practice service 7. Choice of intervention (1 to 6 above) 8. Comparator: Exercise advice + membership to leisure centre (Participants in this group will not be provided with any specific exercise programme) Total duration of interventions: 12 weeks
Intervention type	Other
Primary outcome measure	Weight at 3 months follow-up
Secondary outcome measures	1. Weight loss at 1 year 2. Self-reported physical activity using the International Physical Activity Questionnaire-Short version (IPAQ-Short) at 3 and 12 months 3. Percentage weight loss at 3 months and 1 year
Overall study start date	26/01/2009
Completion date	03/01/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	740
Key inclusion criteria	1. Aged at least 18 years, both males and females 2. Body mass index greater than or equal to 30 (based on data recorded via NHS Quality and Outcomes Framework [QoF]) 3. Identified by GP as medically competent to enter the programme evaluation
Key exclusion criteria	1. Unable to understand English 2. Women who are known to be pregnant 3. Not willing to be randomised
Date of first enrolment	26/01/2009
Date of final enrolment	03/01/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Unit of Public Health, Epidemiology and Biostatistics

Birmingham
B15 2TT
United Kingdom

Sponsor information

NHS South Birmingham (UK)
Government

c/o Dr Jim O'Brien
Head of Clinical Governance
8th Floor
Triplex House
Eckersall Road
Kings Norton
Birmingham
B38 8SS
United Kingdom

Website	http://www.southbirminghampct.nhs.uk/

Funders

Funder type

Government

NHS South Birmingham (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/11/2011		Yes	No